Phase 4
N=52
Regional Anesthesia Following Pediatric Cardiac Surgery
Atrial Septal Defect · Ventricular Septal Defect · Pain, Procedural
Bottom Line
View on ClinicalTrials.gov: NCT05688670 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Total Amount of Opioid Medications Administered — 0.44; 0.83 MME/kg — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Regional Anesthesia (Procedure); Wound infiltration (Procedure); Ropivacaine 0.2% Injectable Solution (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Amount of Opioid Medications Administered |
0.95; 1.57 | 0.004 sig |
| SECONDARY Total Amount of Opioid Medications Administered |
0.95; 1.57 | 0.004 sig |
| SECONDARY Total Amount of Opioid Medications Administered |
0.95; 1.57 | 0.004 sig |
| SECONDARY Postoperative Pain Intensity AUC |
45.0; 94.5 | 0.002 sig |
Summary
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
Eligibility Criteria
Inclusion Criteria
- Children less than 18 years old
- Presenting for primary atrial septal defect or ventricular septal defect repair
- Informed consent / assent provided
Exclusion Criteria
- Patients on opioid therapy at the time of surgery
- History of sternotomy
- Planned postoperative intubation
- Current diagnosis of a chronic pain syndrome.
Data sourced from ClinicalTrials.gov (NCT05688670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.